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Pharmacovigilance Scientist (Associate Director)

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Pharmacovigilance Scientist (Associate Director)

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Job ID SR0049804 Date posted 05/29/2020 Location Cambridge, Massachusetts

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Safety Analytics and Reporting Lead (Associate Director) in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Safety Analytics and Reporting Lead, you will be empowered to Innovate and Strategize.

OBJECTIVE

  • Provides strategic leadership and safety expertise, including support for regulatory submissions and responses, aggregate reports, white papers, etc. 
  • Expert from safety science perspective in primary therapeutic area
  • Potential Global Safety Lead for one compound
  • Flexible outside of primary therapeutic area(s) as directed by business and departmental need

ACCOUNTABILITIES

  • Serve as the Lead Safety Scientist
  • Responsible for reviewing, analyzing, and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications of making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety
  • PV science expert for designated compound(s) within primary therapeutic as appropriate oversees safety and process activities within these therapeutic areas.
  • Integral to GST and GCDT and assisting with writing/reviewing of aggregate reports including the RMP.
  • Direct, mentor, and develop PV Science colleagues commensurate with his/her experience.
  • Ability to functions as senior contact for safety related matters to cross functional groups and external bodies.
  • Maintains compound and more general safety expertise
  • Provides strategic and technical expertise and leadership. Sets medical, scientific and process standards for all products within these therapeutic areas.
  • Contributes to clinical program and protocol design, safety risk management, signal detection. 
  • Oversees PV reports and submissions in designated therapeutic area(s), e.g., aggregate reports and regulatory submissions.
  • In collaboration with the PV TA Lead, leads evaluation and management of emergent safety issues.
  • Ensures adequate internal support and external resourcing (CRO & BPO) to deliver all safety reports.
  • Ensures adequate distribution of assignments and prioritization of tasks within the PV specialist’s staff.
  • Interfaces with functional areas within and outside PV.

REQUIREMENTS

  • Minimum 7 years experience in Pharmacovigilance with significant experience in preparing regulatory documents.
  • Bachelor’s degree required.  Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
  • Comprehensive understanding of PV process in aggregate submissions and the new regulations that have been established.
  • Demonstrated experience in people management and well-developed skills in team building, motivating and developing people.
  • Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements
  • Excellent organization skills and ability to prioritize individual and team work loads.
  • Excellent written and oral communication skills including ability to present to large internal/external groups
  • Capability to synthesize and analyze data from multiple sources.
  • Expertise in pre and post marketing SD.
  • Demonstrated leadership skills with proven ability to motivate and work in multidisciplinary teams.

ADDITIONAL

  • Experience in the support of post marketing surveillance and reporting to Regulatory Authorities worldwide.
  • Strong understanding of the clinical development and regulatory process.
  • Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting.
  • Competence in conducting safety data reviews for investigational and/or post marketed products.
  • High level of expertise and experience in the preparation of aggregate safety reports, including ICH-compliant PBRERs and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of aggregate safety reports.
  • Experience with MedDRA and drug coding reviews.
  • Ability to contribute to and review standard operating procedures and other process-related documents.
  • Excellent communication, collaboration and networking skills.
  • Strong understanding of the interface between Pharmacovigilance and external departments.
  • Ability to influence others within a matrix environment. 
  • Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Forward-planning and proactive.

TRAVEL

Some travel to global Takeda sites may be required.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0049804

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